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Evaluation of Preexisting Immunity Markers in Human Tumor Tissue Sample

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00568867
First Posted: December 6, 2007
Last Update Posted: April 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Stanford University
December 4, 2007
December 6, 2007
April 11, 2011
September 2006
December 2008   (Final data collection date for primary outcome measure)
Not Provided
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Complete list of historical versions of study NCT00568867 on ClinicalTrials.gov Archive Site
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Evaluation of Preexisting Immunity Markers in Human Tumor Tissue Sample
Evaluation of Preexisting Immunity Markers in Human Tumor Tissue Sample
The purpose of this study is to evaluate markers of immune response in human tumor samples.
Cancer immunotherapy has been shown to be effective in isolated instances, but ineffective in most patients. The reason for this inconsistency, and the conditions necessary for successful immunotherapy, are not well understood. Our studies in animal tumor models indicate that the effectiveness of IL-12-based immunotherapy depends upon the presence of a preexisting immune response to the tumor. The presence of T cell infiltrates and IFN-gamma expression in tumor indicate such an immune response. We therefore plan to evaluate the existing immune response in human tumor samples in an effort to identify those patients most likely to respond to therapy with IL-12.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
tumor tissue sample
Non-Probability Sample
Any adult patient with a tumor who is scheduled to undergo surgery to either remove or biopsy the tumor.
Cancer
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
December 2008
December 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:Any adult patient with a tumor who is scheduled to undergo surgery to either remove or biopsy the tumor.

Exclusion Criteria:Patients without tumor and pediatric patients (children) will be excluded.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00568867
SU-11072007-830
97310 ( Other Identifier: Stanford University Alternate IRB Approval Number )
VAR0018 ( Other Identifier: Stanford University )
Yes
Not Provided
Not Provided
Jeffrey A. Norton, Stanford University School of Medicine
Stanford University
Not Provided
Principal Investigator: Jeffrey A. Norton Stanford University
Stanford University
April 2011